Software Quality Engineer II

Genesis10 is currently seeking a Software Quality Engineer II for a 6-month position with a client located in San Diego, CA. This position is 100% remote.

Compensation: $40.00 - 42.00 per hour, W2.

Description:
This position will support quality activities and projects to successfully meet department and corporate goals. This position will require a mastery of understanding, interpreting, and implementing FDA and international regulations, and using the guidance to create and maintain department procedures. Key contributors in authoring and leading the development life cycle of a project. Support and collaboration for one or more areas of business support software, and IT compliance, including, but not limited to:

• Maintaining the Quality Management System, FDA, and International Regulations and Standards.
• Providing expert guidance to teams working within an FDA-regulated environment.
• Mapping and creating diagrams for enterprise systems.
• Creating system and functional risk assessments, requirement documentation, validation plans, and reports.
• Supporting software development project teams.
• Continuous Improvement.
• Additional quality responsibilities as assigned.
• Have a mastery-level understanding of the Software Development Life Cycle (SDLC).

Responsibilities:

• Maintain the Quality Management System and evaluate software and business processes to comply with existing and new FDA and International regulations.
• Ability to lead a project’s software development lifecycle as the Quality Lead.
• Author documentation and guide the entire Software Development Life Cycle (GxP, Part 11, Requirements, Validation, and Summary documentation).
• Provide mastery guidance on the proper use of wording for a requirement and provide test guidance on its testability.
• The ability to understand large enterprise systems and experience working as a Quality Engineer with large enterprise software systems such as SAP, Cloud PLM, Oracle, Camstar, etc.) Communicate with teams and provide quality guidance on a project team.
• Be able to learn technical jargon quickly and communicate with software engineers and IT.
• Communicate with small teams, peers, and management.
• Provides guidance and support with Quality solutions affecting and defining the Quality Management System.
• Supports new regulation gap analysis and updates to the Quality Management System.
• Support IT enterprise systems infrastructure, complex IT systems, implementation, deployment, post-improvements, and maintenance.
• Ensure compliance with Domestic and International quality management systems.
• Supports continuous improvement and review of the Quality Management System.
• Create and approve complex system test case scripts, automation scripts, approvals, and validation support.
• Create engineering deployment and network diagrams for the system and applications.
• Guides data migration planning, scripting, and reporting.
• Works closely with IT and Quality to ensure compliance with numerous agencies and requirements

Must-Have Essential Skills:

• Must have experience interpreting FDA guidance and translating that information into SOPs and process instructions for the company.
• Direct experience with Quality Management Systems, Enterprise Computer Systems risk management, and validations preferred.
• Must be able to present to small teams.
• Collaborative, able to work effectively with diverse functional groups.
• Must demonstrate diligence for compliance, technical competence, and sound judgment associated with each essential duty and responsibility.
• Must have experience guiding teams during validation activities.
• Experience in understanding workflow and deployment diagrams.
• Experience working in a Quality capacity on large, multi-layered Enterprise-level systems.

Experience and Education Requirements:

• Bachelor’s degree in a technical discipline
• 5 – 7 years of related work experience.
• Experience working within a regulated environment required, with some prior team lead or managerial experience preferred.

Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

About Genesis10
Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client.

Benefits of Working with Genesis10:

• Access to hundreds of clients, most of whom have been working with Genesis10 for 5-20 years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF, and Illinois)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website www.genesis10.com.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.